Speaker 1 00:05 Lange, welcome to HelixTalk, a podcast presented by the Rosalind Franklin University College of Pharmacy. Narrator - Dr. Abel 00:11 This podcast is produced by pharmacy faculty to supplement study material and provide relevant drug and professional topics. Speaker 1 00:19 We're hoping that our real life clinical pearls and discussions will help you stay up to date and improve your pharmacy knowledge. Narrator - Dr. Abel 00:27 This is an educational production copyright Rosalind Franklin University of Medicine and Science. Speaker 1 00:32 This podcast contains general information for educational purposes only. This is not professional advice and should not be used in lieu of obtaining advice from a qualified health care provider. Narrator - Dr. Abel 00:47 And now on to the show. Dr. Sean Kane 00:51 Welcome to HelixTalk. I'm Dr. Kane. I'm Dr. Schuman, and I'm Dr. Patel. For those of you who don't know, HelixTalk is the new, rebranded podcast for Rosalind Franklin University's College of Pharmacy, the Speaker 2 01:03 new content will not only include the top 200 drugs, but it will include current topics in pharmacy, drug class reviews, professional topics, etc. And if you want Speaker 3 01:12 to hear anything about a specific topic, just email us. We'd love to hear some of your feedback on things that may be interesting to you. Dr. Sean Kane 01:18 No worries if you really wanted to go back to some of our older, top 200 drugs podcasts. They're all still under the same URL, and you can access them at HelixTalk.com so without further ado, today we're talking about the new lipid guidelines that were released by the ACC and AHA in 2013 and we're going to talk about how they impact clinical practice. Speaker 2 01:40 So we were long due for these guidelines. We had ATP three guidelines published in 2001 and also the same organization then came up with an update in 2004 so between 2004 and 2013 there are a lot of good studies that came about that needed to be summarized and put into practice. So this is what the Accha 2013 Speaker 3 02:01 guidelines are doing so as far as what's new, the main thing with that is that these LDL goals, boom, they're no longer exist. As far as many people are concerned. That's okay, it seems, because they were never really evidence based the idea that association does not prove causation. Speaker 2 02:16 But the interesting thing is, though, that the panel makes no recommendation for or against the use of this goal directed therapy for either the primary or secondary prevention. So basically, they direct clinician direct or dependent approach. Yeah. Dr. Sean Kane 02:31 So the big thing here is, at least in pharmacy school, I learned certain statins lower your LDL by a certain percent, and it was a table to memorize for your exam and things like that, maybe a pocket card to carry, but really in clinical practice now, what they're recommending is more of a clinician driven approach, where you kind of do what you think is reasonable. And for many patients, what the guidelines are recommending is kind of a flat, fixed dose of a statin, where you don't monitor an LDL necessarily, and you don't necessarily have to achieve a certain goal if, if you don't think that that's important for your Speaker 3 03:04 patient, so it's Well, the main thing it did is it kind of shut the door on some of the non statin therapy, such as the fibrates, niacin, the bile acid sequestrants and even ezetimibe or the Omega threes. And that's okay, because it never really showed that those medications minimize some of the atherosclerotic cardiovascular disease outcomes. And so with them going out and with the statins really taking the primary approach, that's fine. What we can do, though, is use them, maybe in cases of mixed dyslipidemia, such as using fibrates, niacin, omega threes. If there's somebody who has their triglycerides that are way high, maybe above 500 and we're concerned about pancreatitis. Dr. Sean Kane 03:41 So to put it into perspective, many of these medications are approved only on the basis of improving your numbers, so it makes your LDL look beautiful, makes your HDL look great. But the problem is that that's not actually the outcome we want. We want people to have fewer myocardial infarctions, and we want people to have fewer strokes. So if it doesn't have that clinical benefit, but it makes your numbers look pretty. What have we really accomplished here? And that's kind of the core problem with the idea of an LDL goal, or many of these newer or really old agents that they may make your lipids look great, but if it doesn't actually improve clinical outcome, then what are we really doing? We're just treating a number or maybe adding more side effects, exactly. That's a huge problem, side effects, cost, those are things that as pharmacists, we should be very cognizant of and try to avoid those things in our patients. Speaker 2 04:29 So another thing that's guidelines, it is to divide the patient groups, aka the benefit groups. What type of patient should we consider statin therapy for? So the main four groups are as following. First one is the individual with clinical atherosclerotic cardiovascular disease, such as if the patient had previous myocardial infarction or stroke. The second group is individuals who have primary elevation of the LDL, either 190 or over. Here we then also have individuals who are between the age of 40 and 75 years with either type one or type two diabetes, who have LDL levels ranging between 70 to 189 without any clinical atherosclerotic cardiovascular disease. And the last group is our individuals without clinical atherosclerotic vascular disease or diabetes, who are 40 to 75 years of age, who has LDL ranging between 70 289 and who also have the 10 year as CBD, risk of 7.5% Speaker 3 05:35 or higher. And when we say this atherosclerotic cardiovascular disease or this ascvd, what we're talking about is a 10 year risk of having an MI or a stroke. And then there's the Framingham, which is also a 10 year risk estimation tool, but that one only included the MI and not the stroke. So that ascvd, it's designed to account for both sex and race specific models, and that should improve accuracy, specifically in African American patients who may not have been as well represented in some of those past tools we use, and there's also these nice risk estimator apps which are available for both iOS and Android devices. Dr. Sean Kane 06:09 So let's go ahead and break down the groups. And I think that as a pharmacist or someone who may potentially recommend statin therapy, it's really important to have an idea of what four groups that the guidelines say should absolutely get a statin. So the first group again was, if you've had an MI or stroke, you get a statin. Speaker 2 06:26 The second one is for even the primary prevention for patients who have LDLs of greater than or equal to 190 Speaker 3 06:33 and a third group of patients who could benefit from a statin would be those individuals that are between 40 and 75 who have either type one or type two diabetes and maybe an LDL between 70 and 189 who don't have that clinical ASCVD. Dr. Sean Kane 06:46 So in other words, it's basically diabetics who have a reasonable LDL, who have not had an MI or a stroke before. Speaker 2 06:54 And the fourth group, again, is for the primary prevention. These are the patients who do not have previous mi or stroke do not have diabetes, but they are in between the range of 40 and 75 who have significantly high LDL level and whose the risk score, the 10 year risk score, is 7.5% or higher. Yeah. Dr. Sean Kane 07:15 So if you take a look at the guidelines, one of the criticisms of the guidelines is that these four criteria may be too inclusive, particularly the last one, where you're age 40 to 75 you have no diabetes, no MI, no stroke, and your LDL isn't terrible. And those patients, the guidelines are recommending that many of these patients should receive a statin. And if you actually look at the ascvd risk equation, the calculation for it's very age sensitive, meaning that as you go up in your age, your risk of having an mir stroke goes up a lot. And many patients who are in their sixth and seventh decade of life will often meet the ascvd cut off of seven and a Speaker 2 07:56 half percent, and they will be automatically be put on or qualified to receive statin therapy, exactly. Speaker 3 08:02 But I think the nice thing it does do is, once you come out of that range of 75 that it becomes more of a decision up to the clinician. So again, not every single individual in the world that that's 80 years of age is going to may you necessarily benefit from a statin at that same so again, at that point, it's up to the clinician individually. Dr. Sean Kane 08:19 I think it's important to note that it's not that statins don't work when you turn 76 it's just that those patients typically weren't included in the trials to show benefit and generally with life expectancy considerations, and given the benefit that we see with the statins in an age group greater than 75 it may not be cost beneficial for them to actually take a statin. Speaker 2 08:40 So as you're reviewing the guidelines, you would also find that these statins are divided into three categories, high intensity statins, moderate intensity statins and low intensity statins. And basically these definitions come from the current clinical trials. Speaker 3 08:57 So some of those examples of medications which may be considered a high intensity statin could be atorvastatin or the brand named Lipitor, either at an 80 milligram dose or at a 40 milligram dose, if an individual was unable to tolerate the 80 milligram dose. Second, one of these agents may be rosuvastatin or Crestor at either 20 milligrams or 40 milligram doses. Dr. Sean Kane 09:17 These bigger, more high intensity statins are going to be appropriate for the patients who have had an MI, who have had a stroke, or patients who have that really high LDL level of 190 or those who have an ascvd risk greater than seven and a half percent, which was that cut off of whether or not you should get a statin Speaker 2 09:35 or not any of your high intensity statins. Qualified patients cannot tolerate the statins due to their side effect, we always have an option to consider them for moderate intensity statins, some of the example for moderate intensity would be doses such as atorvastatin, 10 milligrams, rosuvastatin, 10 milligrams, simvastatin, 20 to 40 milligrams, and pravastatin 40 milligrams. Speaker 3 10:00 Yes. And another reason to maybe consider a moderate intensity stat would be for individuals who have a clinical ascvd and their age greater than 75 or maybe they're having drug interactions as well. That may be a concern about going too high too quickly. Yeah. Dr. Sean Kane 10:14 And that really harps on the point that when you get at a certain age, there's definitely a risk benefit ratio that you have to consider. So not only are elderly patients potentially more inclined to have a myopathy from a statin, but they're also less likely to receive benefit because their life expectancy is shorter than someone who is 55 years old, for example. So kind of as takeaway points from these new guidelines, I think that there's a couple things to think about. One is that the idea of a non statin therapy. So we talked about niacin, omega threes, bile acid sequestrants and ezetimibe. You know, the guidelines aren't recommending these therapies as your go to therapy for a dyslipidemic patient or someone who's at risk for a new mi or a new stroke. And I think that that's important. And the reason, again, is that we just haven't seen clinical benefit with these agents. Dr. Schuman, I'm sure that you've probably seen your fair share of omega threes at the VA Yes. Speaker 3 11:06 We have a fair number of individuals who are put on a fish oil regimen, who maybe are either just out of the range of LDL, just above goal, or what we previously defined as goal, or with triglycerides that are slightly elevated above 150 or who have a bit of a low HDL, but again, based upon with these the new guidelines, unless those triglycerides are grossly, grossly elevated, well above 500 and somebody, especially if they have risk of ascvd, maybe we want to consider looking at a low dose of a statin as tolerated, but again, not always necessarily having to push it as high as we can go, but just To consider them with using a little bit of that clinical decision making and risk benefit knowledge. Speaker 2 11:45 And as pharmacists, we should also consider the benefits of TLC, the Therapeutic Lifestyle changes. So some of these patients who have mixed dyslipidemia, such as high triglycerides or low HDL, what we can recommend for them is to maybe control their sugars, include high fiber, fresh vegetable, fresh fruit, type of diet, and also include a proper exercise regimen that's recommended, Dr. Sean Kane 12:09 and if they smoke they shouldn't. So the other thing that I wanted to point out is that we have this new cut off of the seven and a half percent for our ascvd risk, which is your 10 year risk of having an MI or a stroke. And a lot of the criticism around the guidelines have come about the fact that they picked seven and a half percent instead of 10 or 20% which was present in kind of historical guidelines and historical recommendations. So do you guys have any opinion on the seven and a half versus 10 versus 20 and kind of where you think the cut point should be? Speaker 3 12:40 I think it's difficult, because anytime you establish a cut off point, there are going to be individuals slightly above it or slightly below it. They're going to look totally different. And you're still going to have to exercise a little bit of that clinical judgment to decide whether or not this person on one side of it's going to benefit the same way as somebody who may be squeezing by on the other end of that spectrum. Speaker 2 12:58 And some of those other factors you mentioned, Dr. Schuman, is what we need to decide, is family history of atherosclerotic disease, or what their baseline LDL level is, or what's their lifestyle like? Are they completely off on their diet and living a sedentary lifestyle, or even consider obesity? Dr. Sean Kane 13:18 Yeah, and that's one of the other criticisms of the new guidelines is that when you use this ascvd risk calculation, it doesn't take into account things like your LDL. It doesn't take into account your family history. We know from previous guidelines that those are things that are important. We know from previous trials that those are things that are important. And the authors of the ascvd paper talk about we would have loved to include things like LDL or family history, but in our model, we couldn't make it look significant enough that it should be included. So the way that they come up with this is a big regression algorithm to see what factors are important, which ones aren't, and how important are they are based on your age, your race, your gender. So it's not that those aren't important, but in the modeling that they used, in the database that they use, they just couldn't find those as significant variables. So clinically, we know they're important, which would probably include them in our clinical decision making process. It's just that that's not part of the model. Speaker 2 14:15 So what you were saying, Dr. Kane, here is that obtaining complete patient history and background is really important, besides just plugging and chugging this information into the Risk Calculator, Dr. Sean Kane 14:25 exactly what you'll find is some patients, when they know that their benefit from receiving a statin is only a couple percentage points of absolute benefit of not having an in my air stroke, they may say, it's not worth it to me to go from 9% to seven or 6% of my risk, because many patients won't receive any benefit from statin statistically, some will, some won't. And if you consider adverse effects, cost, drug interactions, pill burden, many elderly patients may choose to not receive the medication when they actually understand what is the risk and the benefit of the therapy. Speaker 3 14:57 Well, like Lange thing this, this is still going to require. A good, honest discussion with your clinician. Any of these, it never needs to be a rubber stamp on every single patient. So for those listening, you know, if it is worth it, is worth discussing with your clinician, or if your clinician discuss with your patients, taking into those individuals, risks, concerns that past history, some of those intangibles, maybe that aren't as apparent, just simply based upon the guidelines. Dr. Sean Kane 15:20 So to kind of summarize the discussion today, again, we're talking about these new guidelines that were published in 2013 by the ACC and the AHA. And my take home point is that, you know, statins are the King of lipid therapy. So for almost any patient where you're trying to reduce their cardiovascular risk, and I'm not necessarily saying, make their LDL look pretty statins are the way to go. For a long time, we thought Omega three is a nice and as an example, were great therapies that would improve your HDL or make your LDL better if the statin wasn't getting you there. But within the past couple years, we've had trials that have shown that those don't improve your cardiovascular endpoints. So we're kind of background back to ground zero. Of statins are the King of therapy for lipid therapy. Speaker 2 16:05 And second thing, don't forget your four main benefit groups. The first one is your secondary prevention, patient who had previous mi or stroke. The second two more are your primary prevention, where LDL is greater than or equal to 190 or their 10 year as CVD risk score is 7.5% or higher, and the fourth group is your individual with either type one or type two diabetic who do not have clinical atherosclerotic cardiovascular disease. Speaker 3 16:33 And remember that number of 7.5% then that's that new ascvd cutoff point. Again, it's not 10, it's not 15, it's 7.5 and that's a number, but that's it's a cut off, but it's something that can be, somebody can be a little bit below, a little bit above it. Just take it into account, and then looking at some of these other intangible factors as well. Dr. Sean Kane 16:53 So I hope today's discussion has updated some of the pharmacy students that have may have had a lipid therapy lecture already, but may be unfamiliar with the new guidelines, or perhaps a practicing clinician that wanted a refresher on what these new guidelines say. Speaker 3 17:07 So again, thank you all very much for listening, and we hope that you'll provide feedback on some other topics in the future. Speaker 2 17:13 And as always, for those students who are studying study hard, Narrator - Dr. Abel 17:19 thank you for listening to this episode of HelixTalk for more information about the show, please visit us at HelixTalk.com. You.